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Titanoréïne Lidocaine Cream for Hemorrhoids
Titanoréïne Lidocaine Rectal Cream is indicated for the local treatment of hemorrhoids and anal fissures. This is an over-the-counter medication that treats the symptoms of hemorrhoidal crisis locally, including itching (pruritus) and associated pain.
The formula of Titanoréïne Lidocaine cream includes 2.5 g of carrageenates, 2 g of titanium dioxide, 2 g of zinc oxide, and 2 g of lidocaine (per 100 g).
The excipients in the composition of the cream are: macrogol palmitostearate, saturated polyglycosylated glycerides, dimethicone, microcrystalline cellulose, methyl parahydroxybenzoate (E219), propyl parahydroxybenzoate (E217), potassium sorbate, and purified water.
Dosage of Titanoréïne Lidocaine Cream This hemorrhoid cream is to be used rectally. It is recommended to apply 0.5 to 2 g with a minimum interval of 3 hours between applications. Moreover, the duration of treatment with Titanoréïne Lidocaine should not exceed 7 days. This medication is intended for use by adults and children over 6 years old.
Contraindications of Titanoréïne Lidocaine Hemorrhoid Cream This medication should not be used during pregnancy or breastfeeding. It is also contraindicated in cases of allergy to any component of Titanoréïne Lidocaine cream. In any case of doubt, it is advisable to seek medical advice.
Packaging: 20 g tube.
Please Read the following full disclosure before purchasing or using this product.
PRODUCT CHARACTERISTICS SUMMARY
ANSM - Updated on: April 24, 2023
- NAME OF THE MEDICINE
TITANOREINE WITH LIDOCAINE 2 PERCENT, cream
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Carrageenates............................................................................................................ 2.50 g
Titanium dioxide...................................................................................................... 2.00 g
Zinc oxide................................................................................................................. 2.00 g
Lidocaine................................................................................................................... 2.00 g
For 100 g of cream.
Noteworthy excipient(s): propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate.
For the complete list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Cream.
- CLINICAL DATA
4.1. Therapeutic indications
Symptomatic treatment of painful and itching anal manifestations, particularly in hemorrhoidal crisis.
4.2. Dosage and method of administration
Dosage
Medical advice is required before use in children.
Adult and child over 6 years: 1 application (0.5 to 2 g) renewable as needed, with a minimum interval of 3 hours between applications.
The duration of treatment should not exceed 7 days.
Method of administration
For topical use.
Rectal route.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
It is necessary to seek medical advice before use in children.
The administration of this product does not replace the specific treatment of anal disease.
If symptoms do not quickly subside, treatment should be discontinued and a proctological examination is essential.
This medicine contains 500 mg of propylene glycol per 100 g of cream and may cause skin irritation.
This medicine contains methyl and propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
Due to the presence of lidocaine:
Repeated treatment should be avoided.
Repeated or prolonged treatment at the mucosal level may expose to the risks of systemic toxic effects of contact anesthetics (central nervous system damage with convulsions, depression of the cardiovascular system).
4.5. Interactions with other drugs and other forms of interactions
The data available to date do not suggest the existence of clinically significant interactions.
4.6. Fertility, pregnancy, and breastfeeding
Pregnancy
As a precaution, it is preferable to avoid the use of this medicine in pregnant women, due to the lack of exploitable clinical data.
Breastfeeding
Lidocaine can be excreted in breast milk in very small quantities. The excretion of carrageenates, titanium dioxide, or zinc oxide in breast milk is uncertain. As a precaution, it is preferable to avoid using this medicine in breastfeeding women.
4.7. Effects on the ability to drive vehicles and use machines
TITANOREINE WITH LIDOCAINE 2 PERCENT, cream has no or negligible effect on the ability to drive vehicles and use machines.
4.8. Adverse Effects
Adverse effects are classified by frequency, using the following classification: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).
Organ System
Frequency
Adverse Event
General disorders and administration site conditions
Frequency not known
Application site reactions may include burning, erythema, exfoliation, irritation, pain, pruritus, rash, urticaria
Immune system disorders
Frequency not known
Hypersensitivity
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows for continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/
4.9. Overdose
No symptoms of overdose in carrageenates, titanium dioxide, and zinc oxide have been identified in the post-marketing data analysis.
The risk of overdose is unlikely considering the low dosage of lidocaine contained in TITANOREINE WITH LIDOCAINE 2 PERCENT, cream.
Exceptional cases of anal ulcerations have been reported with prolonged treatment duration. The application of massive doses could potentially lead to an overdose; in this case, monitoring in a specialized environment should be maintained for several hours due to delayed absorption. Systemic symptoms of an overdose of local anesthetics (all pharmaceutical forms) may include effects on the central nervous system and cardiac effects. Symptomatic treatments should be instituted.
- PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: MEDICINES FOR THE TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE - LOCAL ANESTHETICS, ATC code: C05AD.
Topical in proctology.
A mucoprotector and lubricant of the ano-rectal mucosa, it protects against mechanical or chemical aggressions mainly due to stercoral contacts.
Carrageenate (extract from Rhodophyceae algae) provides a colloidal, film-forming mucilage in a moist environment, capable of intimately applying to the inflamed or injured mucosa and to the stool, facilitating its sliding and evacuation.
Furthermore, carrageenate maintains contact of the other inert and protective topical components with the mucosa.
The presence of lidocaine base, a contact anesthetic, in the cream produces rapid analgesia (about 15 minutes) whose duration, variable among individuals, can extend from 1 to 3 hours, or more.
5.2. Pharmacokinetic properties
Toxicological studies have not significantly demonstrated tissue migration of the medicine, which is eliminated during defecation.
5.3. Preclinical safety data
Ortho-toluidine (a metabolite of prilocaine) and 2,6-xylidine (a metabolite of lidocaine) have shown mutagenic properties in vitro and a carcinogenic potential at high doses in chronic toxicity studies in animals.
It is not considered that these data imply a particular risk in humans, given the route of administration, the doses used, and the duration of treatment.
- PHARMACEUTICAL DATA
6.1. List of excipients
Macrogol palmitostearate, saturated polyglycolysed glycerides, dimethicone, microcrystalline cellulose, propylene glycol, methyl parahydroxybenzoate (E219), propyl parahydroxybenzoate (E217), potassium sorbate, purified water.
6.2. Incompatibilities
Not applicable.
